Adolescent Probiotics in Stressed Adolescents

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT07565883
Status
Completed

Conditions

  • Cognitive Ability, General
  • Emotions
  • Immune System Function

Eligibility Criteria

Sex
ALL
Age
12 Years - 20 Years
Healthy Volunteers
Accepted

Interventions

  • Probiotics — DIETARY_SUPPLEMENT
    The participants started taking capsules the day after the first visit, after collecting the AM saliva sample, and continued taking them daily (preferably with a dinner meal) for 12 consecutive weeks. If the probiotic was not taken during dinner, it should be taken within 2 hours after dinner or with the next meal
  • placebo — DIETARY_SUPPLEMENT
    The participants started taking placebo capsules the day after the first visit, after collecting the AM saliva sample, and continued taking them daily (preferably with a dinner meal) for 12 consecutive weeks. If the probiotic was not taken during dinner, it should be taken within 2 hours after dinner or with the next meal

Study Details

Stress is a normal human reaction to changes surrounding our reality, resulting in physical, emotional, and intellectual responses. Children and adolescents often experience high levels of stress. Age and gender may affect a child's ability to manage stress. Children and adolescents experiencing stress could be at an increased risk of poor cognitive, social, and emotional functioning. Probiotics are living microorganisms that could positively affect microbiota, support functions of numerous organs and systems, and overall human health. Most probiotics belong to the Lactobacillus genus. Probiotics can potentially support mental health, psychological function, and immune defenses. The purpose of this exploratory clinical trial is to investigate whether supplementation of the diets of adolescents experiencing moderate stress with the probiotic dietary supplement a blend of two probiotic Lactobacillus plantarum and one Lactobacillus brevis strains will support their emotions (e.g., psychological well-being, social relationship, stress levels, and self-efficacy), cognitive (e.g., attention, episodic and working memory) and immune functions (e.g., salivary IgA and salivary cytokine productions). This study is intended only to evaluate the dietary supplement's effect on the body's structure or function. Our investigation is not intended to mitigate, cure, treat, or prevent disease.

Key Dates

Start date
May 3, 2022
Status verified
Apr 2026
Primary completion
Jul 22, 2024
Completion
Nov 25, 2024

Study Design

Enrollment
104 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Probiotics supplement
    Participants received the probiotics blend containing two Lactobacillus plantarum and one Lactobacillus brevis strains for 12 weeks. The probiotic blend contained 2 billion CFU bacteria. Stains are present in the mixture at a ratio of 2:1:1. Participants were taking them daily with meals, (preferably with a dinner meal) for 12 consecutive weeks. If the probiotic was not taken during dinner, it should be taken within 2 hours after dinner or with the next meal
  • Placebo Comparator: Placebo cohort
    The participants started taking placebo capsules the day after the first visit, after collecting the AM saliva sample, and continued taking them daily (preferably with a dinner meal) for 12 consecutive weeks. If the capsule was not taken during dinner, it should be taken within 2 hours after dinner or with the next meal

Primary Outcome Measure

Emotinal status and cognitive functions of participants [ Time Frame: From enrollment (week 0), 8 weeks and 12 weeks (end of study) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Division Clinical Pharmacology, SOM, University of UtahSalt Lake CityUtah84108-
University of Utah, Pediatrics and Primary Childrens HospitalSalt Lake CityUtah84108-

Find similar trials in Salt Lake City, UT

By research site
Division Clinical Pharmacology, SOM, University of Utah· Salt Lake City, UTUniversity of Utah, Pediatrics and Primary Childrens Hospital· Salt Lake City, UT

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